Method and apparatus for sonographic examination, biopsy, and excision

Abstract

Method and apparatus for internal examination of human and other subjects employing special catheters and biopsy wires, in combination with sonographic or fluoroscopic transducers, to provide unprecedented accuracy, economy, and efficiency in internal examination, diagnosis, biopsy, and surgical removal of lesions, tumors, polyps, etc. from bodies. In one aspect the invention provides an apparatus for use in combination with a sonographic transducer for examination and performing biopsies within a vaginal and uterine chamber of a human female and other bodies, whereby the apparatus is comprised of a substantially tubular catheter and any of a wide variety of biopsy devices adapted for disposition on or within the catheter. In another aspect, the invention provides a method of using sonographic or fluoroscopic imaging in combination with the apparatus to examine the cavities under study and to guide the apparatus during a biopsy procedure.

I claim:  
     
       1. An apparatus for use in combination with a sonographic transducer for examination and performance of biopsies within a uterine chamber and a vaginal chamber of a human female and other bodies, the apparatus comprising: 
       (a) a substantially rigid tubular catheter having an anterior end, a posterior end, an exterior surface, and an interior lumen;  
       (b) the external surface that is viewable by commonly known ultrasonic and radiographic imaging techniques, such that the catheter is adaptable for use in combination with sonographic examination of uterine and endometrial abnormalities;  
       (c) a substantially tapered tip that is offset from the central axis of the catheter located at the anterior end of the catheter;  
       (d) a distal port continuous with said internal lumen at said tapered tip;  
       (e) at least one bumper affixed to the anterior end of the catheter proximal to said tip, such that the catheter is insertable at least as far as the vaginal chamber, whereby the depth of catheter insertion is limited by a body cavity passage such as the cervix;  
       (f) at least one fender located along the external surface of the catheter, proximal to said bumper, whereby the catheter is supportable in a selected juxtaposition relative to the uterine chamber;  
       (g) a biopsy device coaxially disposed within the catheter and slidably engaging the internal lumen of the catheter, said biopsy device being longitudinally and rotationally positionable within said catheter, whereby said biopsy device is inserted into the uterine chamber through the catheter, and operationally manipulated while disposed therein; and  
       (h) a port at the posterior end of the catheter, whereby said biopsy device is removable (with or without a biopsy sample) and replaceable by an alternate biopsy device while the catheter remains in a fixed operational position within a body cavity.  
     
     
       2. The apparatus of  claim 1 , whereby said catheter is comprised of at least two coaxially-disposed catheters (one catheter being located inside another), with the biopsy device being disposed within an inner catheter. 
     
     
       3. The inner catheter of  claim 2 , further comprising a flexible, and substantially tubular body having an anterior end and a posterior end, the anterior end of said inner catheter is curved, whereby the biopsy device is extensively positionable within said uterine chamber. 
     
     
       4. The apparatus of  claim 2 , further comprising an inflatable balloon adapted to prevent contact between a side of the catheter and a wall of the uterine chamber, such that, when inflated, the balloon prevents accidental removal of the catheter from the uterine chamber, and provides a fluid-tight seal withing the inner chamber. 
     
     
       5. The apparatus of  claim 1 , whereby the fender is comprised of an inflatable balloon. 
     
     
       6. The apparatus of  claim 1 , wherein the tip of said catheter is curved. 
     
     
       7. The apparatus of  claim 1 , further comprising a semi-rigid and flexible tip. whereby said tip provides extensive directional movement while inhibiting inoperable deformation during use. 
     
     
       8. The apparatus of  claim 1 , wherein said catheter posterior and anterior tip ports, and internal lumen receive a biopsy or excision device that has a diameter between 3 and 7 french (1.00 millimeter and 2.33 millimeters respectively). 
     
     
       9. The apparatus of  claim 1 , further comprising a sealable posterior port providing a fluid-tight passage for introduction, operation, and removal of a biopsy device therein. 
     
     
       10. The apparatus of  claim 1 , wherein said catheter is comprised of a plurality of fenders providing a means to support the catheter, whereby the catheter is supportable in a selected juxtaposition relative to the uterine chamber. 
     
     
       11. The apparatus of  claim 10 , wherein said fenders are comprised of at least one bumper, whereby the catheter is supportable against a wall of the vaginal chamber, thereby restraining the catheter from insertion beyond a desired depth within the uterine chamber. 
     
     
       12. The apparatus of  claim 1 , wherein the biopsy device is further comprised of a blade, whereby said blade is engageable with tissue within the uterine chamber, and is retractable during deployment and withdrawal of the tissue. 
     
     
       13. The apparatus of  claim 1 , further comprising at least one secondary lumen for aspirating the tissue from the uterine chamber. 
     
     
       14. The apparatus of  claim 1 , wherein the biopsy device comprises an excision device adapted for the removal of tissue from the uterine chamber and selected from the group comprising forceps, snares, baskets, cauterizing devices, suction aspiration catheters, reverse bias blades, and brushes. 
     
     
       15. The apparatus of  claim 1 , wherein the anterior end of said catheter comprises at least one side port. 
     
     
       16. A method for the sonographic examination of a multi-chambered body cavity comprising a uterine chamber, and a vaginal chamber communicating with the uterine chamber, and for the removal of tissue from the cavity, the method comprising the steps of: 
       inserting a substantially tubular catheter into the vaginal chamber at least as far as the vaginal chamber;  
       inserting an excision device into the uterine chamber through the catheter; inserting a sonographic transducer within the vaginal chamber in substantial proximity to the uterine chamber, whereby sonographic examination of the uterine chamber is enabled;  
       sonographically examining the uterine chamber;  
       sonographically guiding the excision device to an abnormality within the uterine chamber;  
       sonographically locating the abnormality within the uterine chamber;  
       removing a biopsy tissue sample of the abnormality with said excision device; and  
       removing said excision device and tissue sample through the catheter, whereby the catheter and sonographic transducer remain in their inserted positions for continued operation.  
     
     
       17. The method of  claim 16 , further comprising the step of infusing an intraluminal fluid into the cavity to facilitate sonographic examination of the uterine chamber. 
     
     
       18. The method of  claim 17 , wherein the intra luminal fluid is introduced to the uterine chamber via the catheter. 
     
     
       19. The method of  claim 16 , further comprising the step of determining the thickness of a tissue wall by means of sonographic imaging. 
     
     
       20. The method of  claim 16 , further comprising the step of determining the homogeneity of a tissue wall by means of sonographic imaging. 
     
     
       21. The method of  claim 16 , wherein the excision device comprises a snare and the method further comprises the step of engaging and removing polyps. 
     
     
       22. The method of  claim 16 , wherein the excision device is selected from the group consisting of a forceps, basket, and brush.